RU2735990C1 - Device for fixation of surgical needle holders - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medical equipment, namely to surgical instruments intended for retention and actuation of surgical needle during sutures, and can be used in proctology when performing a hemorrhoid suturing and hemorrhoid dearterialization, in cardiosurgery to suture an opening in the heart cavity by forming a U-shaped or Z-shaped suture, in general surgery for stitching of bleeding vessel in narrow canal with poor visibility. Device for fixation of surgical needle holders comprises two channels parallel to each other, rigidly connected to each other, each of which is configured to accommodate laparoscopic needle-holder with possibility of its only longitudinal movement inside channel. Channels are formed in the body, in which at least one additional channel is formed, which is intended for the auxiliary element placement during the operation.

EFFECT: using the invention enables maintaining the surgical needle control during the operation, improving the operational reliability, reducing the time of suturing and providing atraumaticity.

8 cl, 14 dwg

Description

The invention relates to medical equipment, namely to surgical instruments designed to hold and actuate a surgical needle in the process of suturing, and can be used in proctology when performing the operation of stitching a hemorrhagic node and dearterialization of hemorrhoids, in cardiac surgery for suturing a hole in the heart cavity due to the formation of a U-shaped or Z-shaped suture, in general surgery for suturing a bleeding vessel in a narrow channel with poor visibility.

Currently, devices are widely known for holding only one surgical needle with only one needle holder during an operation.

Known needle holder [invention patent RU 2222273, publ. 27.01.2004], containing two spring-loaded, pivotally connected by the axis of the branch with the working jaws. On the inner side of the branch there are symmetrical segment grooves, in which an elastic ring is fixed.

Also known is a needle holder [patent for invention RU 2223053, publ. 02/10/2004], which contains pivotally connected jaws with ring handles and ratchet. The handles are connected to the jaws through a tubular body and a rod, which is located in the body. One jaw has a wedge shape with a clamping radius working surface. The working surface of the other jaw has a longitudinal support depression of a trapezoidal shape, while the depth and width of the longitudinal support depression corresponds to the radius of the curved surgical needles.

Other variants of single needle holders are also known, for example, a patent for a useful model RU 182975, publ. 06.09.2018, patent application CN 110403656 (A), publ. 05.11.2019, utility model patent CN 209518892 (U), publ. 10/22/2019, as well as HiQ + laparoscopic needle holders (Olympus Surgical Technologies product catalog. Electronic resource. Access mode to the resource: https://pdf.medicalexpo.ru/pdf-en/olympus-america/hiq-series/789

04-153829.html # search-en-laparoscopic-needle-holder - free, date of circulation 03/29/2020).

All known needle holders have a common drawback, which is the lack of constant control (holding) of the surgical needle in the process of sewing tissues, since after sewing the needle remains in the tissues and it must be removed with tweezers or the same needle holder, grabbing the needle by the nose that emerged from the tissues. Tweezers do not always firmly grip the needle, if the tip of the needle has just appeared over the stitched tissues, and without firmly gripping the nose of the needle, the latter can disappear into the tissues due to their elasticity. An additional single needle holder is not always convenient to insert into a narrow wound to maintain control over the needle.

The aim of the present invention is to provide such a device that will allow you to maintain control over the surgical needle during the operation with the achievement of the technical result, which consists in atraumatism, increased operational reliability and reduced suture time.

The specified technical result is achieved due to the fact that the device for fixing the surgical needle holders includes two parallel channels, rigidly connected to each other, each of which is configured to accommodate a laparoscopic needle holder with the possibility of only longitudinal movement within the channel.

Special cases of the main technical solution are possible:

- each channel is formed by at least two frames located on the same axis and rigidly attached to each other and between other frames of the second channel;

- each channel is formed by a tube;

- the channels are rectangular;

- the channels are equipped with a means for preventing rotation of the needle holder;

- channels are formed in the body;

- at least one additional channel is formed in the housing, intended for the location of the auxiliary element in it during the operation;

- an additional channel is configured to accommodate a surgical thread;

- an additional channel is configured to accommodate an ultrasound sensor;

- the additional channel is configured to accommodate a video camera.

Thus, the proposed device, when equipped with two needle holders, is, in fact, a double needle holder and will allow you to maintain control over the surgical needle during the operation, since the needle will always be in one or both of the needle holders. Rigid fixation of the needle holders relative to each other ensuring their only longitudinal movement will allow to reliably intercept the needle when suturing the tissues, which will reduce the trauma of the surgical intervention and reduce the time of suturing. At the same time, due to the simple design of the device, its operational reliability is increased.

FIG. 1 shows an embodiment of a device with a rectangular cross-section of channels.

FIG. 2 shows an embodiment of the device with a circular cross-section of channels.

FIG. 3 shows a variant of the device according to claim 3 of the formula.

FIG. 4 shows an embodiment of the device according to claim 4 of the formula.

FIG. 5 shows a classic laparoscopic needle holder.

FIG. 6-8 show the principle of operation of one needle holder located in the channel.

FIG. 9-12 shows an embodiment of the device in the housing according to claim 6 of the formula.

FIG. 13 shows an embodiment of the device with a protective cover.

FIG. 14 is an illustration for an example.

The device for fixing surgical needle holders (Fig. 1-14) includes two parallel channels 1 and 2, rigidly connected to each other, each of which is configured to accommodate the laparoscopic needle holder 3 and 4 with the possibility of only longitudinal movement within the channel 1 and 2, respectively.

Each channel 1, 2 can be formed in different ways and have a different cross-sectional shape.

Each channel 1, 2 can be formed using at least two frames (Fig. 1, 2) located on the same axis and rigidly fastened to each other and between other frames of the second channel, for example, using rods 5, while the frames can have a round or rectangular section. The size of the frames is selected depending on the required stroke of the needle holders 3, 4, placed in them, to prevent the needle holders 3, 4 from falling out. The frames can be equipped with slots 6, 7.

In another embodiment, each channel 1, 2 can be formed by a tube (Fig. 3), while the tubes are rigidly connected to each other and can have both circular and rectangular cross-sections. A slot 6, 7 can be formed in each tube.

A variant is possible when channels 1, 2 are formed by U-shaped channels (Fig. 4), rigidly connected to each other, with means 8, 9 for fixing the needle holders 3, 4 inside channels 1, 2, respectively.

Needle holders 3, 4 have an identical design. Each needle holder 3, 4 can be a classic laparoscopic needle holder (Fig. 5), then it is necessary to work with the device using both hands in order to ensure the unclenching of the branches of the needle holders.

A variant is possible when each needle holder 3, 4 is specially configured for use in the claimed device. So the needle holder 3 is a needle holder of the laparoscopic type (Fig. 6-8), consisting of two curved parts (rectangular or circular cross-section), fastened together to form branches 10, 11, for which there is a means 12 provided with a spring 13. Needle holder 3 can be assembled in its body or directly directly in the channel 1. There may also be a spring 14 for pushing the needle holder 3 out of the channel 1. In the case when the channels 1, 2 are circular (Fig. 2, 3), they should be equipped with a means for preventing rotation of the needle holder 3, 4. This can be represented by means 12 for unclenching the jaws 10, 11, placed in the slots 6, 7, or other rotation limiters located also in the slots 6, 7 or in additional slots (in the drawing not shown). The size of the slot 6, 7 corresponds to the required longitudinal travel of the needle holders 3, 4.

The means 12 for unclenching the jaws 10, 11 should only open the jaws 10, 11 and provide the possibility of successive displacement of one and the second needle holder 3, 4 at the time of stitching (Fig. 6-8). The jaws 10, 11 are in a permanently closed state and the opening occurs only due to the means 12 for unclenching the jaws 10, 11, which can be made in the form of a control button (bracket, spring, or handle, if remotely - using a remote pull). FIG. 6 to 8 sequentially depict the principle of operation of the means 12. FIG. 5 shows another embodiment of the means 12 for unclenching the jaws 10, 11, made in the form of a handle from a scissor.

In the case of a rectangular channel 1, 2 (Fig. 1, 4), the channel itself serves as a rotation limiter and provides only longitudinal movement of the needle holder 3, 4 with a rectangular section. However, the channels 1, 2 can be additionally equipped with seals (not shown in the drawing), which also prevent the rotation of the needle holders 3, 4.

Channels 1, 2 can be formed in a common body 15 (Fig. 9-13). Channels 1, 2 in the body 15 can be formed in three ways: 1 - longitudinal channels are drilled in the solid cylinder of the body 15; 2 - other tubes of a smaller diameter are inserted into the body 15, fixed to the walls, the remaining cavities are filled with a biologically inert substance (for example, silicone); 3 - the body 15 is filled with a biologically inert substance (for example, silicone), in which channels of the required size are drilled.

Two rigidly interconnected needle holders 3, 4 are necessary to prevent the loss of the needle 16 (Fig. 10-12) in the tissues and for the purpose of constant control of the needle 16 (not to let go of the needle holders 3, 4, but to reliably intercept it when sewing the tissues).

At the inlet of each channel 1, 2 (in the proximal part), a valve (not shown in the drawing) can be located for sealing, if the device is used in a hollow organ. Instead of a built-in valve in each channel 1, 2, an introducer sheath with a hemostatic (air) valve (not shown in the drawing) can be used, through which all components can be inserted.

In the housing 15, at least one additional channel 17, 19, 21 can be formed, designed to accommodate an auxiliary element therein during an operation.

An additional channel 17 can be configured to receive a surgical thread 18 (Fig. 9-12).

Additional channel 19 can be configured to accommodate ultrasound probe 20 (Fig. 9-12), which will allow tissue to be traced at the depth of suture.

The additional channel 21 can be configured to accommodate a video camera 22 (Fig. 9-12), with which it is possible to stitch in the depth of the intestine.

Other technological channels 23 (Fig. 9, 11, 12) can also be formed in the housing 15, for example, for removing fluid in a wound or for insufflation of gas (for example, carbon dioxide or air).

Unused additional channels can be closed with plugs (not shown in the drawing).

The body 15 can be provided with a protective cover 24 (Fig. 13). The cover 24 is made with the possibility of displacement and is designed to protect the internal structures from accidental damage when the ultrasound sensor 20 and jaws 10, 11 of the needle holders 3, 4 are pulled out of the body 15 already in the cavity of the operated organ. FIG. 13, cover 24 is shown in an extended state. The cover 24 covers only the extendable parts and does not interfere with the ultrasound examination and injection of the needle 16. At the time of stitching, it is displaced in the proximal direction (pushed back), without interfering with the interception of the needle 16 after stitching the tissues. Particularly important is the role of the lid 24 for the proctological instrument, in order to push back the intestinal wall for visualization through the video camera 22. After the cover 24 is extended, the video camera 22 is pulled out, allowing to examine the opposite intestinal wall.

The diameter of the body 15 is in the range of 10-30 mm (for various sizes of atraumatic needles used in various fields of surgery).

Channel diameters 1, 2 are in the range of 5-8 mm. The diameter of the channel 19 for the intracardiac ultrasound probe 20 is in the range of 5-6 mm, the diameter of the channel 17 for the thread 18 is in the range of 1-2 mm.

Rotation of needle holders 3, 4, inserted into channels 1, 2, is not allowed. In canals 1, 2, each needle holder 3, 4 can only move along canals 1, 2, protruding from its distal end by 10-25 mm and move backward, entering canals 1, 2, respectively. Thus, each of the two needle holders 3, 4 should be equal in length or shorter than channel 1, 2. The length of the entire device on average ranges from 10-15 cm for cardiac surgery and up to 30 cm for general surgical use. The length of the working surface of the branches 10, 11, emerging from the common body 15 - 10-25 mm. Needle holders type 3, 4 - permanently closed. Unclenching the jaws 10, 11 is possible only when the needle 16 is gripped or released. Slot 6, 7 should be 10-25 mm long to move both needle holders 3, 4 along channel 1, 2 by the length of the jaw.

The needle holders 3, 4 can be controlled not only through the slots 6, 7, but also from the proximal end of the channels 1, 2, but only two movements remain unchanged - open-close the jaws 10, 11 of the needle holder 3, 4 and back and forth movement distance up to 10-25 mm.

Channels 1, 2 and slots 6, 7 on the lateral surface of the body 15 are located at such a distance that the needle 16, simultaneously captured by two needle holders 3, 4, is firmly fixed and does not change position relative to the body 15 when sewing fabrics, i.e. needle 16 should be grasped 2-5 mm from the point and 2-5 mm from the heel. Thus, for each needle 16 (17 mm, 22 mm or other size) there must be its own body 15, in which the distance between channels 1 and 2 must correspond to the size of the used needle 16.

It can be provided for the simultaneous simultaneous pushing in and out of both needle holders 3, 4 from the body 15 and fixation in the retracted position in the body 15 (like a pistol safety catch or a bracket fixed to the body 15) with the ability to remove this fixation in one movement, holding the body 15 in one hand.

Sewing is carried out only due to the rotational movement of the entire body 15 (if there is no body, then connected channels 1, 2), sequentially releasing and pushing into the body 15 the 1st and 2nd needle holders 3, 4, while the needle 16 is constantly monitored either two or one of the needle holders 3, 4 and is never fully released.

The claimed device is used as follows.

Both needle holders 3, 4 are firmly fixed each in the corresponding channel 1, 2 in such a way that the extension of the working part (sponge) from the distal opening of the channel 1, 2 is possible only by 10-25 mm forward and backward. Both needle holders 3, 4 can be extended simultaneously or each separately.

In the initial state, both needle holders 3, 4 hold the needle 16 and are in the retracted position into the channels 1, 2. The needle 16 is also located inside the housing 15 near its distal end. After inserting the device through the introducer into the fluid cavity, it is possible to move out of channel 1, 2 first by the ultrasound probe 20, and then both needle holders 3, 4 by removing the retainer that held them in channel 1, 2 while passing through the introducer.

Extension from channel 1, 2 forward by 1-2.5 cm of both needle holders 3, 4 with the captured atraumatic needle 16 and thread 18 should be carried out synchronously after insertion of the device into the intestinal cavity, atrium, narrow wound or other body cavity where suturing of the vessel is required (eg, bladder, cyst).

Separate retraction into channels 1, 2 in succession of each needle holder 3, 4 (after the release of the needle 16 by one needle holder 3 or 4) can be carried out by means 12 for unclenching the jaws 10, 11 through the slots 6, 7. The needle 16 must be captured by one or two needle holders 3, 4.

Suturing of fibrous tissue when suturing an interatrial defect (cardiac surgery) and forming a U-shaped suture or Z-shaped suture in the atrial cavity under ultrasound and X-ray control is carried out by rotating the entire device with the end (1st) needle holder retracted 4. When the needle end 16 emerges from the fabric, it is captured by the end (1st) needle holder 3, after which the heel (2nd) needle holder 4 opens and is pulled into channel 2. After that, the stitching is completed by further rotation of the entire device. When the heel of the needle 16 comes out of the fabric, it is captured by the heel (2nd) needle holder 4. The U-shaped seam is made. Needle 16 is fixed with two needle holders 3, 4.

In the future, 2 options are possible:

1st. The entire device is removed from the introducer, the threads are fixed in the thread holder. It turns out a U-shaped seam.

2nd. A second similar seam is made 5-10 mm from the previous one, and a Z-shaped seam is formed.

Tying the threads is possible by analogy with tying with a laparoscopic extracorporeal knot with bringing it down through the introducer, or it is possible to fix the threads using clips with the CorKnot apparatus.

For use in proctology, the following channels should be provided in the housing 15: instead of the ultrasound sensor 20 in the upper part, the channel will be operated by a video camera 22 with a light guide; and in the lower part there will be additional two channels: one for ultrasound probe 20 (5-8 mm) and manipulation (5-8 mm) for supplying air, water or sucking the contents. In total, the proctological device will have only 6 through channels: two for needle holders 3, 4, one for thread (1-3 mm), one video channel (5-8 mm), one ultrasound channel (5-8 mm) and one manipulation channel (5-8 mm).

The device should be inserted into the rectum in the assembled state with 15 components pushed into the housing. It is possible to use a rubber sleeve with a hole in the center when inserted into the rectum. After the introduction of the instrument into the rectum, the distal end of the instrument is freed from the sheath, exposing the openings of all 6 channels. After insertion into the rectum, the video camera 22 is displayed first. For this, it is necessary to provide for the possibility of longitudinal rotation (preferably discrete - by 45 degrees) for visual control of the position of each of the needle holders 3, 4. After selecting the appropriate point on the rectal mucosa, it is removed from the body 15 Ultrasound probe 20 x 10-20 mm to determine the rectal artery (Doppler mode). After that, it is possible to remove both needle holders 3, 4 under video control. Stitching should be carried out under video control (injection, release of the 16 needle and its subsequent capture after stitching) and ultrasound control (Doppler). With a shallow arrangement of the threads from the level of the external opening of the anal caral, they can be tied, with a deep one - clipping of the knot.

In the case of using a device for general surgery (Fig. 13), traditional suturing of a narrow channel in the tissues (for example, when the liver is injured, a large muscle mass with bleeding deep in the tissues) is possible only with a wide dissection of tissues and stitching of all bleeding zones. This instrument can be used when suturing a deep narrow canal without additional dissection of organ tissue. A positive element of using the proposed instrument is the possibility of ultrasonic scanning of the canal to clarify the zone of the alleged source of bleeding under the layer of liquid (including blood) and suturing it with ultrasonic control of the termination of blood flow through the bringing vessel. Tying a knot is carried out according to laparoscopic principles or clipping of threads is possible.

Claims (8)

1. A device for fixing surgical needle holders, including two parallel channels, rigidly connected to each other, each of which is configured to accommodate a laparoscopic needle holder with the possibility of its only longitudinal movement within the channel, while said channels are formed in a housing in which at least one additional channel is formed, designed to accommodate an auxiliary element therein during an operation. 2. A device for fixing surgical needle holders according to claim 1, characterized in that each channel is formed by at least two frames located on one axis and rigidly fastened to each other and between other frames of the second channel. 3. A device for fixing surgical needle holders according to claim 1, characterized in that each channel is formed by a tube. 4. A device for fixing surgical needle holders according to claim 1, characterized in that the channels have a rectangular cross-section. 5. A device for fixing surgical needle holders according to claim 1, characterized in that the channels are provided with means for preventing rotation of the needle holder. 6. A device for fixing surgical needle holders according to claim 1, characterized in that the additional channel is configured to accommodate a surgical thread. 7. A device for fixing surgical needle holders according to claim 1, characterized in that the additional channel is configured to accommodate an ultrasound probe. 8. A device for fixing surgical needle holders according to claim 1, characterized in that the additional channel is configured to accommodate a video camera therein.

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